The main outcome for the study was adrenaline and noradrenaline levels in neonatal umbilical cord blood. Measurements of umbilical venous and arterial pH were obtained. Incidence of neonatal respiratory distress, Apgar score of the newborn, need for mechanical ventilation and proportion of neonates requiring admission into intensive care unit were also assessed.

Notes

The ethics committee of the tertiary neonatal care institution where the study was carried out provided ethics approval.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer-generated random numbers.

Allocation concealment (selection bias)

Low risk

Sealed, coded, opaque, sequentially numbered envelopes.

Blinding of participants and personnel (performance bias) All outcomes

Low risk

Intervention group given prostaglandin E2 gel and control group given an equal volume of K-Y jelly.

Independent research assistant administered trial drug or placebo to participants.

There was no neonate requiring mechanical ventilation in either groups.

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Moderate

All cause fetal mortalityFollow-up: 1 day.

Study population

Not estimable

36(1 study)

⊕⊕⊝⊝low1

There was no reported neonatal death in the study.

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Maternal adverse events

Study population

Not estimable

36(1 study)

⊕⊕⊝⊝low1

There was no maternal adverse event reported in the study.

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*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidenceHigh quality: further research is very unlikely to change our confidence in the estimate of effect.Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.Very low quality: we are very uncertain about the estimate.

1 The optimal information size was not met, confidence intervals were wide and event rates were low.